scope:

This Standard specifies requirements for urethral catheters, with or without a balloon, which are used for urethral catheterization, pressure hemostasis, cleaning of bladder, etc. (hereafter referred to as catheters). This Standard does not apply to nephrostomy catheters and cystostomy catheters to be placed through a stoma covered by ISO 20697.

NOTE 1 Requirements for ureteral stents are specified in JIS T 3270.

NOTE 2 The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 20696 : 2018 Sterile urethral catheters for single use (MOD)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standards and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.